The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures Against COVID–19. 86 Fed. Reg. 41977 (August 4, 2021).

The PREP Act (42 U.S.C. 247d-6d), originally enacted in 2005, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against epidemics and pandemics. Vaccines are biologics and, as such, are authorized by FDA as COVID-19 countermeasures under the emergency use law. The PREP Act empowers HHS to issue declarations that immunize covered entities and individuals from tort liabilities that could stem from the use of countermeasures such as coronavirus vaccines to combat disease and/or threats deemed to constitute a public health emergency.

The PREP Act was amended in 2020 to create liability immunities and a compensation program in the face of the COVID-19 pandemic, with a Jan. 31, 2020 Declaration of a public health emergency for the entire United States, to aid in the response of the nation’s health care community to the COVID-19 outbreak.

The Secretary of HHS has now issued an eighth amendment to the public health emergency Declaration to clarify that qualified pharmacy technicians and interns are Qualified Persons covered by the Declaration, and to expand the scope of authority for qualified pharmacy technicians to administer seasonal influenza vaccines to adults within the state where they are authorized to practice and for interns to administer seasonal influenza vaccines to adults consistent with other terms and conditions of the Declaration. This clarification includes consideration of vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP’s standard immunization schedule, including the seasonal influenza vaccine.

As there will be a need for the U.S. adult population to receive both COVID-19 and seasonal influenza vaccines throughout the 2021-2022 influenza season, additional qualified persons to administer the vaccines will be needed.

Health risks may increase for individuals who contract seasonal influenza concurrently with COVID-19. While influenza incidence was lower than anticipated last fall and winter (2020 – 2021), the Secretary believes the same cannot be assumed for the 2021-2022 flu season, as many states have largely lifted the community mitigation measures previously in place at the height of the COVID-19 pandemic. Seasonal influenza has the potential to inflict significant burden and strain on the U.S. healthcare system in its own right; and in conjunction with the ongoing COVID-19 pandemic, a spike in influenza cases could overwhelm healthcare providers. Like the vaccination against COVID-19, the vaccination against influenza requires many people to be vaccinated within a short period of time, potentially creating a surge on the system. The eighth amendment to the PREP Act adds and/or clarifies that pharmacy interns and technicians, under proscribed circumstances, can aide in the vaccination efforts.

This alert does not purport to be a substitute for advice of counsel on specific matters.

Harris Beach has offices throughout New York State, including Albany, Buffalo, Ithaca, Long Island, New York City, Rochester, Saratoga Springs, Syracuse and White Plains, as well as New Haven, Connecticut and Newark, New Jersey.